Efficacy, Safety, and Durability of Brolucizumab: An 8-Month Post-Marketing Surveillance Analysis

Abstract

Importance

Brolucizumab (Beovu^®) is an anti-vascular endothelial growth factor (anti-VEGF) agent approved for the treatment of neovascular age-related macular degeneration (nvAMD). Brolucizumab was marketed for its noninferiority to aflibercept and its potential for greater durability. However, post-marketing utilization has been tempered by safety concerns.

Objective

We evaluate the visual and anatomic efficacy of brolucizumab, examine changes in treatment intervals after switching to brolucizumab, and estimate the incidence of drug-related adverse events in the real world.

Design, Setting, and Participants

This was a retrospective consecutive case series of 626 eyes (543 patients) with nvAMD treated with 1438 brolucizumab injections at a single retina practice between 10/1/2019 and 5/15/2020.

Main Outcomes and Measures

Changes in visual acuity (VA); anatomic outcomes assessed by optical coherence tomography (OCT) including central subfield thickness (CST), macular volume (MV), presence of intraretinal fluid (IRF), subretinal fluid (SRF), and serous pigment epithelial detachment (sPED) on foveal line scans; treatment intervals before and after receiving brolucizumab; and the incidence of brolucizumab-related adverse events.

Results

The majority of eyes (N = 531, 89.7%) had received prior anti-VEGF therapy with aflibercept, ranibizumab, and/or bevacizumab. VA improved in treatment-naïve eyes (+3.7 letters, p = 0.04), and was maintained in previously treated eyes. There were significant improvements in all anatomic outcomes in both groups (p < 0.001). We observed a 4.8% incidence of intraocular inflammation (IOI) and a 0.6% incidence of retinal vasculitis. The average treatment interval increased from 6.3 to 6.8 weeks (p = 0.001).

Conclusions and Relevance

Brolucizumab treatment was associated with VA improvement in naïve eyes and maintenance of VA in previously treated eyes. Switching to brolucizumab was associated with improved anatomic outcomes and extended treatment intervals in most eyes. We observed a similar incidence of IOI and a lower incidence of retinal vasculitis compared to the Safety Review Committee’s analysis of HAWK and HARRIER.

Keywords:

• Beovu
• brolucizumab
• anti-VEGF
• intraocular inflammation
• retinal vasculitis

Acknowledgments

The preliminary results of this analysis were presented at The Association for Research in Vision and Ophthalmology (ARVO) meeting in May 2021 and at the American Society of Retina Specialists (ASRS) meeting in October 2021. The poster’s abstract was published in “Poster Abstracts” in Investigative Ophthalmology & Visual Science June 2021, Vol.62: https://iovs.arvojournals.org/article.aspx?articleid=2774044

Disclosure

Scott D. Walter is a speaker for Apellis, Bausch and Lomb, Genentech/Roche, Regeneron, and Spark Therapeutics; and a consultant for Allergan, Aura Biosciences, Bausch and Lomb, Castle Biosciences, Genentech/Roche, EyePoint Pharmaceuticals, Ideaya Biosciences, Lupin, Novartis, and Regeneron. Nicholas J. Saba reports no conflicts of interest for this work.

Additional information

Funding

There is no funding to report.